- Astellas Pharma (Northbrook, IL)
- …of commercial products within a within a region. + Responsible to be a Regional Regulatory lead or Global Regulatory Lead , for development programs ... Leads regulatory development in GRL or regional regulatory lead roles in the context of...Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in… more
- AbbVie (Mettawa, IL)
- …specialist medical and scientific input into core strategic and operational medical affairs activities for AbbVie's Oncology portfolio such as: health-care ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The R&D Regulatory Affairs Finance team supports the leadership in strategic ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...(Long Range Plan) and Latest Best Estimate (LBE) for Regulatory Affairs . The primary function of the… more
- Astellas Pharma (Northbrook, IL)
- …in remote work are encouraged to apply. **Purpose and Scope:** The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within ... Accountabilities:** Strategic Statistical Leadership + Serve as the compound-level statistical lead for solid tumor oncology , responsible for end-to-end… more
- AbbVie (Mettawa, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Area TA Lead will act as the Intercontinental Neuroscience Lead , providing… more
- AbbVie (Mettawa, IL)
- …Key responsibilities include: + Contributes to the development of brand strategies. + Lead and support Medical Affairs initiatives (strategy and tactics) for ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...regulatory , etc.) as they relate to on-going medical affairs projects. + Works with some supervision and guidance.… more
- AbbVie (North Chicago, IL)
- …team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical Writing. Safety Statisticians ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...+ Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory… more
- AbbVie (Mettawa, IL)
- …They will foster positive working relationships with the sales force, medical affairs , market research, sales training, regulatory , and other cross franchise ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...have direct reports, they must demonstrate the ability to lead without authority and build a collaborative and integrated… more
- AbbVie (North Chicago, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... or research activities across several clinical development programs. May lead cross-functional teams to generate, deliver, and disseminate high-quality clinical… more
- AbbVie (North Chicago, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data… more
- Astellas Pharma (Northbrook, IL)
- … regulatory compliance and timely submissions. + Partner with drug regulatory affairs , clinical trials unit, clinical development, precision medicine teams, ... across all phases of drug development. As a Diagnostic Regulatory Strategy Lead , you will be the...relevant scientific or technical discipline (eg, Life Sciences, Pharmacy, Regulatory Affairs ). Advanced degree is preferred. +… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director, Regulatory Affairs Global Regulatory Strategy is responsible ... secure and maintain market approval for product(s) in the Oncology therapeutic area. Leads the Global Regulatory ...Sr GRL or TA Head. May participate in or lead regulatory and company initiatives. Based on… more
- AbbVie (North Chicago, IL)
- …driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Astellas Pharma (Northbrook, IL)
- …in remote work are encouraged to apply. **Purpose and Scope:** The Medical Lead Oncology , MA-US (Medical Affairs -United States), is accountable for ... more products within the Therapeutic Area (TA). The Medical Lead Oncology , MA-US is responsible for: +...insights into regional and global strategy + Collaborate with Regulatory Affairs and Pharmacovigilance in the development… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** The Therapeutic Area Lead , Early Scientific Engagement & Communications, will lead the strategic ... communications for Astellas early-stage assets, ensuring alignment with the broader oncology and biopharma portfolio strategy. Reporting to the Head of Early… more
- AbbVie (North Chicago, IL)
- …oncology access channels (payer, distribution, IDN, GPO, Clinical Pathways, guidelines) + Lead Oncology Clinical Core Team in the development and execution of ... process. + Development and execution of the medical affairs access/HCDM strategy and tactics across all ...presents medical access considerations at VAT and AST + Lead the development of strategic resources and provide relevant… more
- Astellas Pharma (Northbrook, IL)
- …team, alliance partner, Market Access, Global Marketing, CI, Sales, Training, Regulatory , Legal, Medical Affairs , and agencies. Specific responsibilities will ... **XTANDI Commercial Brand Strategy Lead ** Do you want to be part of...and internal colleagues from other departments (including global, medical affairs , market research, legal, and regulatory ) as… more
- AbbVie (Mettawa, IL)
- …matrixed organization, including (but not limited to): market access, medical affairs , finance, regulatory , legal, supply operations, health economics, clinical ... people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and...development, R&D, public affairs , medical and regulatory review, patient relations,… more
- AbbVie (North Chicago, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... clinical trial execution and the Development and Global Medical Affairs Therapeutic Area MDs/SDs. + Key contributor to the...Reviews and provides clinical operations content to clinical and regulatory documents (eg, INDs, IB, NDAs, BLAs, MAA, … more
- AbbVie (North Chicago, IL)
- …In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs , the appropriate regulatory strategies for ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , Research and Development. Additional Information Applicable… more